Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical (Score-TIH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00748839 |
Recruitment Status
:
Completed
First Posted
: September 9, 2008
Last Update Posted
: November 27, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.
During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.
Condition or disease |
---|
Heparin-induced Thrombocytopenia |
Study Type : | Observational |
Actual Enrollment : | 2700 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV) |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |
- the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests [ Time Frame: inclusion and 40 days after the inclusion ]
- pathogenic nature of anti HPF4 antibodies of IgM and IgA type [ Time Frame: inclusion ]
- new biological test detecting HIT [ Time Frame: inclusion ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
-
all patients presenting, either during or immediately after treatment:
- thrombocytopenia and/or venous or arterial thrombosis
- for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study
Exclusion Criteria:
- do not possess sufficient clinical data prior to performance of the biological test
- cannot assure follow-up of the patient until normalization of the platelet count

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748839
France | |
ETS de Franche Conté - Laboratoire d'Immuno Hématologie | |
Besançon, France, 25020 | |
CHU Cavale Blanche Laboratoire d'Hématologie | |
Brest, France, 29609 | |
Laboratoire d'hématologie - Hôpital Louis Pradel | |
Bron, France, 69500 | |
Hôpital Antoine Beclère - Laboratoire d'hématologie | |
Clamart, France, 92141 | |
Laboratoire d'hématologie - CHU de Clermont Ferrand | |
Clermont Ferrand, France, 63003 | |
HCC Colmar - laboratoire d'hématologie | |
Colmar, France, 68024 | |
Laboratoire d'Hématologie - CHU le Bocage | |
Dijon, France, 21034 | |
Laboratoire d'hémostase - CCML | |
Le Plessis Robinson, France, 92350 | |
Hôpital Cardiologique - Laboratoire d'Hémostase | |
Lille, France, 59037 | |
CHU La Timone - Laboratoire Hématologie | |
Marseille, France, 13385 | |
Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie | |
Montpellier, France, 34295 | |
Hématologie biologique - CHU Nancy | |
Nancy, France, 54511 | |
HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie | |
Nantes, France, 44093 | |
Hématologie Biologique - Hôpital Tenon, | |
Paris, France, 75002 | |
Hôpital Necker Enfants Malades -Laboratoire d'Hématologie | |
Paris, France, 75015 | |
Hôpital BICHAT - Service d'hématologie immunologie | |
Paris, France, 75018 | |
G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran | |
Paris, France, 75851 | |
Hôpital Européen Georges Pompidou - Service Hématologie Biologique A | |
Paris, France, 75908 | |
Hôpital Cardiologique - CHU Bordeaux | |
Pessac, France, 33604 | |
Laboratoire central d'hématologie - Hôpital R. DEBRE | |
Reims, France, 51092 | |
CHU de ROUEN | |
Rouen, France, 76031 | |
Laboratoire d'hématologie | |
Saint-Etienne, France, 42055 | |
Service d'Urgence et de Réanimation | |
Saint-Etienne, France, 42055 | |
CHU Strasbourg Hautepierre Laboratoire d'Hématologie | |
Strasbourg, France, 67098 | |
CMC Foch Laboratoire d'hémostase | |
Suresnes, France, 92151 | |
Hopital Purpan - Laboratoire d'hématologie | |
Toulouse, France, 31059 | |
CHU Trousseau - CTH - Service d'Hématologie Hémostase | |
Tours, France, 37044 |
Principal Investigator: | Bernard TARDY, MD | CHU de Saint-Etienne |
Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT00748839 History of Changes |
Other Study ID Numbers: |
0801016 |
First Posted: | September 9, 2008 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
HIT Heparin-induced thrombocytopenia heparin treatment venous thrombosis |
arterial thrombosis predictive clinical score biological test anti-H-PF4 antibodies |
Additional relevant MeSH terms:
Thrombosis Thrombocytopenia Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Blood Platelet Disorders Hematologic Diseases |
Calcium heparin Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |